Gvoke Pfs Patent Expiration

Gvoke Pfs is a drug owned by Xeris Pharmaceuticals Inc. It is protected by 2 US drug patents filed from 2020 to 2023 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Apr 22, 2036. Details of Gvoke Pfs's patents and their expiration are given in the table below.

Drug Patent Number Drug Patent Title Drug Patent Expiry Status
These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US9649364 Methods for producing stable therapeutic formulations in aprotic polar solvents
Apr, 2036

(11 years from now)

Active
US11590205 Methods for producing stable therapeutic glucagon formulations in aprotic polar solvents
Apr, 2036

(11 years from now)

Active


A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Gvoke Pfs's patents.

Given below is the list of recent legal activities going on the following patents of Gvoke Pfs.

Activity Date Patent Number
Patent litigations
Patent Issue Date Used in PTA Calculation 28 Feb, 2023 US11590205
Email Notification 28 Feb, 2023 US11590205
Recordation of Patent Grant Mailed 28 Feb, 2023 US11590205
Issue Notification Mailed 08 Feb, 2023 US11590205
Application Is Considered Ready for Issue 24 Jan, 2023 US11590205
Dispatch to FDC 24 Jan, 2023 US11590205
Mail Response to 312 Amendment (PTO-271) 23 Jan, 2023 US11590205
Email Notification 23 Jan, 2023 US11590205
Response to Amendment under Rule 312 13 Jan, 2023 US11590205
Pubs Case Remand to TC 12 Jan, 2023 US11590205


FDA has granted several exclusivities to Gvoke Pfs. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Gvoke Pfs, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Gvoke Pfs.

Exclusivity Information

Gvoke Pfs holds 1 exclusivities. All of its exclusivities have expired in 2022. Details of Gvoke Pfs's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
New Product(NP) Sep 10, 2022

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US patents provide insights into the exclusivity only within the United States, but Gvoke Pfs is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Gvoke Pfs's family patents as well as insights into ongoing legal events on those patents.

Gvoke Pfs's Family Patents

Gvoke Pfs has patent protection in a total of 14 countries. It's US patent count contributes only to 40.7% of its total global patent coverage. Click below to unlock the full patent family tree for Gvoke Pfs.

Family Patents

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Generic Launch

Generic Release Date:

Gvoke Pfs's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Apr 22, 2036 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Gvoke Pfs Generic API suppliers:

Glucagon is the generic name for the brand Gvoke Pfs. 1 company has already filed for the generic of Gvoke Pfs. Check out the entire list of companies who have already received approval for Gvoke Pfs's generic

Alternative Brands for Gvoke Pfs

Gvoke Pfs which is used for treating severe hypoglycemia., has several other brand drugs in the same treatment category and using the same active ingredient (Glucagon). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.

Drug Owner Drug Name Treatment Area
Xeris
Gvoke Kit

(uses Glucagon)

Used for quickly raising blood sugar levels in cases of severe hypoglycemia.
Gvoke Hypopen

(uses Glucagon)

Used for treating severe hypoglycemia.

Apart from drugs working in same treatment category, there are also some brand drugs where treatment area is different, but the active ingredient used is same i.e. Glucagon. Given below is the list of those drugs and companies owning them.

Drug Owner Drug Name
Amphastar Pharms Inc
Baqsimi
Zealand Pharma
Zegalogue
Zegalogue (autoinjector)


Apart from brand drugs containing the same ingredient, some generics have also been filed for Glucagon, Gvoke Pfs's active ingredient. Check the complete list of approved generic manufacturers for Gvoke Pfs





About Gvoke Pfs

Gvoke Pfs is a drug owned by Xeris Pharmaceuticals Inc. It is used for treating severe hypoglycemia. Gvoke Pfs uses Glucagon as an active ingredient. Gvoke Pfs was launched by Xeris in 2019.

Approval Date:

Gvoke Pfs was approved by FDA for market use on 10 September, 2019.

Active Ingredient:

Gvoke Pfs uses Glucagon as the active ingredient. Check out other Drugs and Companies using Glucagon ingredient

Treatment:

Gvoke Pfs is used for treating severe hypoglycemia.

Dosage:

Gvoke Pfs is available in solution form for subcutaneous use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
0.5MG/0.1ML (0.5MG/0.1ML) SOLUTION Discontinued SUBCUTANEOUS
1MG/0.2ML (1MG/0.2ML) SOLUTION Prescription SUBCUTANEOUS